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- FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type IaThe U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
- FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kitsThe FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…